A Study to Evaluate the Efficacy and Safety of Standard of Care (SOC) + Standardized Gudmar (Gymnema sylvestre) 250 mg Capsule Versus Standard of Care (SOC) Alone for Glycaemic Index Control and Weight Management in Adults with Type 2 Diabetes.

A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicentric Clinical Study to Evaluate the Efficacy and Safety of Standard of Care (SOC) + Standardized Gudmar (Gymnema sylvestre) 250 mg Capsule Versus Standard of Care (SOC) Alone for Glycaemic Index Control and Weight Management in Adults with Type 2 Diabetes. - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/107908

Enrollment

Registered

2026-04-09

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Age 18 to 65 years either gender Diagnosed type 2 diabetes FPG 126 to 160 mgdL or HbA1c 6.5 to 8 percent BMI 22 32 kgm Stable lifestyle and medications if any for at least 3 months prior Willingness to participate and Able and willing to give written informed consent Compliance: Willing and able to comply with all study procedures visit schedules and follow-up assessments

Exclusion criteria

Exclusion criteria: Disease-Related Criteria Type 1 diabetes or insulin dependent type 2 diabetes Severe hyperglycaemia HbA1c should be greater than 8 percent or hypoglycaemia Uncontrolled thyroid liver kidney or cardiovascular disease History of diabetic ketoacidosis Known gastrointestinal malabsorption or chronic diarrhoea Previous or Concomitant Treatment Related Criteria Use of insulin GLP-1 agonists or investigational products Participation in another clinical study in past 30 days Current use of anti-obesity or appetite suppressant medication Participant Related Criteria Pregnant or breastfeeding women Known allergy to Gudmar or herbal ingredients Any condition interfering with protocol compliance

Design outcomes

Primary

Measure	Time frame
Evaluate the efficacy of Gudmar in reducing HbA1c level and body weightTimepoint: From screening to day 45 and 90	—

Secondary

Measure	Time frame
To evaluate change in fasting plasma glucose (FPG) and postprandial glucose (PPG) To evaluate BMI waist circumference and lipid profile To evaluate safety and tolerability.Timepoint: screening to 90 days	—

Countries

India

Contacts

Public ContactBinay Kumar Naik

Indivirtus Global CRO PVT LTD

medwriter@indivirtus.com7608847619

Outcome results